An insomnia drug to improve daytime functioning, a treatment for a rare type of eye cancer, and an oral migraine drug for both acute and preventive treatment are among 13 new products recommended for pan-EU approval.

The European Medicines Agency will likely decide this week whether to recommend for pan-EU approval new treatments for insomnia, uveal melanoma, migraine and advanced prostate cancer.

While Immunocore is not giving details of what issues it still needs to address regarding its EU filing for tebentafusp, it said the drug is continuing to undergo an accelerated assessment by the CHMP. 

US FDA’s user fee goal calendar for 2022 already contains 45 applications for novel agents featuring a wide array of biologics, from cell therapy in cancer and hematology to bispecifics and new immuno-oncology targets that could move the field beyond PD-1/L1.